Supportive Care Intervention for Outpatient Stem Cell Transplant Patients

Friendi.fi Corporation

Status: Enrolling

Conditions: Hematopoietic Stem Cell Transplantation; Cancer

Treatments: Behavioral: care.coach Avatar™

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06564233

DFCI 24-183

Details and patient eligibility

About

The overall goal of this study is to assess the efficacy of the care.coach Avatar™ in improving anxiety and quality of life for patients undergoing outpatient transplant. After care.coach Avatar™ content and scheduling ("digital intervention" or "program") has been optimized for outpatient allogeneic hematopoietic stem cell transplantation (HCT), a randomized controlled trial (RCT) will be conducted of the digital versus usual supportive care program for outpatient HCT recipients. Potential improvements in anxiety and quality of life will be evaluated, with the intent of increasing comfortability with outpatient transplant and expanding the population of eligible patients willing to receive their transplants in an outpatient setting.

Full description

Allogeneic hematopoietic stem cell transplantation (HCT) is the delivery of multipotent donor-derived stem cells to a recipient patient. It typically involves a lengthy inpatient hospitalization (median 25.8 days). With improving availability of health services, prophylactic medications, and lower infection risk and transfusion requirements, outpatient HCT is becoming more prevalent for patients receiving reduced intensity conditioning (RIC). However, even for outpatient HCT, patients are hospitalized for a median of 8 days. Most symptoms from HCT are concentrated in the first 30-days after the transplant, and these must be better addressed to optimize benefits from outpatient HCT. For patients undergoing HCT, incidence of psychological consequences is higher than in other cancer health states; potential psychological symptoms include stress, anxiety, anger, depression, insomnia, and loneliness. Non-pharmacological approaches for improving quality of life (QOL) and reducing distress among HCT patients include psychoeducational, exercise, and mindfulness interventions. Although post-HCT changes in lifestyle are challenging, the Health Belief Model and Prochaska's Transtheoretical model of change posit that patients preparing for HCT day 0 (notated as D0), when they receive the stem cell infusion, would be highly motivated to learn about psychosocial supports and activities given their readiness for change and taking action. This presents an ideal timeframe for studying a psychosocial health coaching intervention.

Enrollment: 90 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18+
• Seen for outpatient RIC HCT (prior to D0, generally D-6).

Exclusion criteria

• Deemed by clinical staff or research assistant (RA) to be unable to converse with an avatar, due to: severe, uncorrectable hearing or vision impairment; severe speech impairment that precludes understanding by staff (or by the avatar).
• Not fluent in English.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

care.coach Avatar™

Experimental group

Description:

care.coach Avatar™ with usual supportive care. The avatar program includes companionship, HCT educational modules, relaxation and mindfulness exercises, simple (seated) physical exercises, nightly check ins, and symptom self-management as needed.

Treatment:

Behavioral: care.coach Avatar™

Usual Supportive Care

No Intervention group

Description:

Traditional supportive care comprising of a binder with HCT educational materials and regular meetings with a transplant nurse.